ACRE AI

Advancing Clinical Research in Europe with AI-powered Data Framework (ACRE AI)

We aim to create a framework for Clinical Trials that boosts efficiency and reduces barriers using innovative technologies and Real-World Evidence. CliniNote is a Polish technology company based in Warsaw specializing in clinical data solutions. At CliniNote, we believe that the best way to capture high-quality clinical data is by supporting doctors and medical staff in data generation processes while simultaneously collecting data prospectively. With this new framework, we acquire real-time data without adding to the workload of healthcare personnel. This approach has delivered excellent results, particularly in applications like automated data entry for clinical trials and real-world evidence studies. Additionally, this framework can be applied in settings where seamless integration with external systems is desired, enabling real-time, bidirectional communication with healthcare providers. For instance, it allows the use of an external AI model without requiring repeated data entry. Our data entry platform delivers real-time, high-quality, interoperable, and priceless real-world data (RWD) for pharma companies, clinical trials, patient recruitment, hospitals, and other stakeholders in the life sciences industry. Challenges our proposal addresses: 1) Clinical trials in Europe face challenges that slow down research due to diverse languages, regulations, and healthcare systems. ​ 2) High costs and administrative burdens are particularly tough for academic-led studies competing for funding. ​ 3) Cross-border complexity & compliance raises costs, limiting research scope. ​ 4) Integrating Real-World Evidence (RWE) is further hindered by inconsistent data standards, limited cross-border data access, and a lack of interoperability. Our vision is to enhance the efficiency and speed of clinical trials by leveraging AI technology and regulatory advancements, such as European Health Data Space. The challenges outlined in ACT-EU (Accelerating Clinical Trials in the EU) - including complex workflows, administrative burdens, and data integration issues - require innovative solutions. We firmly believe that by effectively harnessing novel technologies and collaborating closely with key stakeholders, alongside necessary regulatory changes, we can revolutionize the way clinical trials are conducted. By collaborating with key industry players, regulators, researchers, and patient representatives, we aim to develop, validate, and widely implement the AI-powered Clinical Research Framework. Through ACRE AI project, we aim to: ✔ Automate and streamline clinical trial data processes, including the patient recruitment and data entry automations ✔ Enhance cross-border collaboration in clinical research ✔ Leverage Real-World Data to accelerate introduction of new drugs ✔ Develop regulatory recommendations to maximize the benefits of implementing the framework Initially, the following parties are interested in participating in the project: a pan-European organization representing over 160 hospitals, a pan-European organization facilitating multinational clinical trials, local and EU regulators, and global pharmaceutical companies.